Spring 2015
Large Pragmatic Studies to Evaluate Patient-Centered Outcomes
PFA Offline Reviewer Critique Template
Please use this template only as a placeholder for your critiques. Once you have finished your
critique, please copy/paste your comments into the PCORI Online Critique Form.
Keep each criterion box to no more than 5000 characters, including spaces. Comments for each
criterion should list out strengths and weaknesses. Comments for the Human Subjects and Overall
Narrative sections should be in written in paragraph form.
Request ID:
Criterion 1: Impact of the condition on the health of individuals and populations
The proposal addresses the following questions:
 Is the condition or disease associated with a significant burden in the US population, in terms
of prevalence, mortality, morbidity, costs to society, individual suffering, or loss of
productivity?
Criterion Score:
Strengths:
Weaknesses:
-
Criterion 2: Potential for the study to improve health care and outcomes
The application has the potential to lead to meaningful improvement in the quality and efficiency
of care and to improvements in outcomes that are important to patients.
 Does the research question address a critical gap in current knowledge as noted in systematic
reviews, guideline-development efforts, or previous research prioritizations?
 Is there strong evidence of support by relevant patient, caregiver, clinician, payer, or
purchaser organizations?
 Is the research novel or innovative in its methods or approach, the population being studied,
or the intervention being evaluated, in ways that make it likely to improve care?
 Do wide variations in practice patterns suggest current clinical uncertainty?
 Do preliminary studies indicate potential for a sizeable benefit of the intervention relative to
current practice?
 How likely is it that positive findings could be disseminated and implemented quickly,
resulting in improvements in practice and patient outcomes?
 Are there adequate plans for sustainability of the successful intervention(s) in the chosen
settings, or discussion of implementation of successful intervention(s) into similar care
settings?
Criterion Score:
Spring 2015
Strengths:
Weaknesses:
-
Criterion 3: Technical Merit
The application has sufficient technical merit to ensure that the study goals will be met.














Is there a clear research plan with rigorous methods that adhere to PCORI’s
Methodology Standards and prevailing accepted best practices?
Is there a clear comparison condition that is a realistic option in standard practice? Is
the comparator sufficiently described to reasonably compare the two or more
conditions in the trial?
Are the proposed comparative conditions currently in use? Is there prior evidence of
efficacy or effectiveness for the interventions being compared?
Is there evidence that the outcome measures are sufficiently sensitive to identify
differences between groups?
Is the study conducted in a patient population that is relevant to the majority of
patients with a condition or to a previously understudied subgroup?
Are the pre-specified subgroups reasonable given the proposed interventions and
condition?
Are the subgroups sufficiently large to allow a rigorous and valid comparative analysis?
Is the budget appropriate for the proposed research?
Is there a clear and adequate justification for the study design choices in the proposed
pragmatic trial?
Is there an adequate plan for protection of human subjects participating in this study?
Do the applicants provide evidence of study feasibility based on availability of
participants and experienced staff for efficient start-up?
Does the project include a realistic timeline that includes clear and specific scientific
and engagement milestones?
Does the research team have the necessary expertise and prior experience in
conducting large-scale multicenter trials as well as an appropriate organizational
structure to successfully complete the study?
Is the research environment, including the delivery systems that will host the study,
well resourced and highly supportive of the proposed study?
Criterion Score:
Strengths:
Weaknesses:
Spring 2015
-
Criterion 4: Patient-Centeredness
The proposal demonstrates patient-centeredness at every stage of the research. It addresses
the questions:
 Is the research focused on questions that affect outcomes of interest to patients and
their caregivers?
 Does the research address one or more of the key questions mentioned in PCORI’s
definition of PCOR?
Criterion Score:
Strengths:
Weaknesses:
-
Criterion 5: Patient and Stakeholder Engagement
The application demonstrates that people representing the population of interest and other
relevant stakeholders are engaged in ways that are appropriate and necessary in a given
research context.
 Are patients and other stakeholders engaged in:
o Formulating research questions?
o Defining essential characteristics of study participants, comparators, and outcomes?
o Identifying and selecting outcomes that the population of interest notices and cares
about (e.g., survival, function, symptoms, health-related quality of life) and that inform
decision-making relevant to the research topic?
o Monitoring study conduct and progress?
o Designing and/or suggesting plans for dissemination and implementation activities?
 Are the roles and the decision-making authority of all research partners clearly stated?
 Does the application demonstrate the principles of reciprocal relationships, co-learning,
partnership, trust, transparency, and honesty?
Criterion Score:
Strengths:
Weaknesses:
Spring 2015
-
Protection of Human Subjects:
Does the application have acceptable risks and/or adequate protections for human subjects?
(Yes/No)
Comments:
Overall Score:
Overall Narrative: